Clinical investigations with medical devices (MDR)
Specific rules for the submission, assessment and conduct of clinical investigations with medical devices are set out in the EU Medical Device Regulation (EU no 2017/745, MDR). These rules are described in Chapter 6 of the MDR.
Clinical investigations with medical devices are divided into different legal frames. These frames are described in Legal framework, guidances and standards.
For information on the submission and contents of the research file, please visit Primary submission and Standard research file medical devices.
During and after the study provides information on what to report during and after the clinical investigation with a medical device.
Information on starting an appeal against or objection procedure to a decision by the accredited MREC or CCMO is available on Appeal and objection.